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Trial record 1 of 1 for:    I6A-MC-CBBE
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A Study of LY3023414 and Necitumumab in Squamous Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02443337
First received: May 11, 2015
Last updated: March 1, 2017
Last verified: March 2017
  Purpose
The main purpose of this study is to evaluate the safety and activity of the study drug known as LY3023414 in combination with necitumumab in participants with metastatic squamous non-small cell lung cancer (NSCLC).

Condition Intervention Phase
Non-small Cell Lung Cancer Metastatic
Drug: LY3023414
Drug: Necitumumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of the Combination of LY3023414 and Necitumumab After First-Line Chemotherapy for Metastatic Squamous Non-small Cell Carcinoma of the Lung

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants with a Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) [ Time Frame: 6 Months ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3023414 and Necitumumab [ Time Frame: Predose Cycle 1 through End of Study Treatment (Approximately 5 Months) ]
  • Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) [ Time Frame: Baseline to Objective Disease Progression (Approximately 3 Months) ]
  • Progression Free Survival [ Time Frame: Baseline to Measured Progressive Disease or Death from Any Cause (Approximately 6 Months) ]
  • Overall Survival [ Time Frame: Baseline to Death from Any Cause (Approximately 9 Months) ]

Estimated Enrollment: 48
Study Start Date: July 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY3023414 + Necitumumab
LY3023414 administered orally twice daily and necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
Drug: LY3023414
Administered orally
Drug: Necitumumab
Administered IV
Other Names:
  • LY3012211
  • IMC-11F8

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed squamous advanced NSCLC (Stage IV).
  • Participants must have progressed on one prior line of platinum-based chemotherapy in the advanced or metastatic setting.
  • Measurable disease as measured by response evaluation criteria in solid tumors (RECIST) criteria v 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Able to swallow the study drugs whole.
  • Adequate organ function.
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed ≤ 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 3 months following completion of study treatment.

Exclusion Criteria:

  • Participants who have received > 1 prior line of chemotherapy in the advanced or metastatic setting. (Immunotherapy will not be considered a line of chemotherapy.)
  • Prior treatment with a PI3K/mTOR inhibitor, epidermal growth factor receptor (EGFR) inhibitor, and/or necitumumab.
  • History of brain metastases unless irradiated ≥ 2 weeks prior to first study treatment and stable without requirement of corticosteroids.
  • Have serious pre-existing medical conditions.
  • Have insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics.
  • Women who are pregnant or breast-feeding.
  • Clinically significant electrolyte imbalance ≥ Grade 2.
  • Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin and oral Xa inhibitors are allowed.
  • Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ≤ 28 days prior to Day 1 of Cycle 1.
  • Concurrent serious infection requiring parenteral antibiotic therapy.
  • Have a second primary malignancy that in the judgment of the investigator and Medical Monitor may affect the interpretation of results.
  • Have an active, known fungal, bacterial, and/or known viral infection.
  • History of arterial or venous embolism within 3 months prior to study enrollment. If the embolism occurred >3 and <6 months, the participant is eligible provided appropriate treatment according to institutional standard of care is ensured.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02443337

Locations
United States, Alabama
Southern Cancer Center, P.C.
Mobile, Alabama, United States, 36608
United States, Arizona
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
United States, Colorado
Comprehensive Cancer Care and Research Institute of Colorado
Englewood, Colorado, United States, 80113
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Florida Cancer Specialists
St. Petersburg, Florida, United States, 33705
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, Ohio
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Chattanooga Oncology Hematology
Chattanooga, Tennessee, United States, 37404
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
United States, Virginia
University of Virginia Health
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Eli Lilly and Company
SCRI Development Innovations, LLC
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02443337     History of Changes
Other Study ID Numbers: 15799
I6A-MC-CBBE ( Other Identifier: Eli Lilly and Company )
Study First Received: May 11, 2015
Last Updated: March 1, 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 24, 2017